BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 3940152 · Received March 21, 2014

    Report

    Report Number
    2024601-2014-00142
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    January 4, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING ADDRESSES REPORTED EVENT OF NECROSIS AS FOLLOWS: "NECROSIS MAY INHIBIT WOUND HEALING AND REQUIRE SURGICAL CORRECTION AND/OR EXPLANATION." "PLACEMENT, EXPANSION AND PRESSURE OF THE REMOTE INJECTION SITE MAY INDUCE NECROSIS PARTICULARLY WITH UNSUITABLE SKIN FLAPS."

    Description of Event or Problem · 1

    REPORTED EVENT OF "T JUNCTION NECROSIS" WITHIN 6 PATIENTS FROM JOURNAL ARTICLE: "SKIN REDUCING MASTECTOMY AND IMMEDIATE RECONSTRUCTION: THE EFFECT OF RADIOTHERAPY ON COMPLICATIONS AND PATIENT REPORTED OUTCOMES", EUROPEAN JOURNAL OF SURGICAL ONCOLOGY: THE JOURNAL OF THE EUROPEAN SOCIETY OF SURGICAL ONCOLOGY AND THE BRITISH ASSOCIATION OF SURGICAL ONCOLOGY, (2014 JAN 22). ELECTRONIC PUBLICATION DATE: 22 JAN 2014. THIS RECORD ADDRESSES THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168321 UNK MAMMARY IMPLANT FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention